510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K863528Substantially Equivalent

Bicondylar Toe Prosthesis

Depuy, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863528 is the FDA 510(k) clearance record for BICONDYLAR TOE PROSTHESIS, cleared for Depuy, Inc. on . FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K863528.

Clearance record

Decision date
Received
(19 days to decision)
Review panel
Unknown
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
Third party review
No